PERMATINT(R)

FDA Premarket Approval P820059 S011

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DevicePERMATINT(R)
Generic NameLenses, Soft Contact, Daily Wear
ApplicantWESLEY JESSEN CORP.
Date Received1986-08-05
Decision Date1986-11-12
PMAP820059
SupplementS011
Product CodeLPL 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonOther Report
Expedited ReviewNo
Combination Product No
Applicant Address WESLEY JESSEN CORP. 333 E. Howard Ave. des Plaines, IL 60018-5903

Supplemental Filings

Supplement NumberDateSupplement Type
P820059Original Filing
S020 1992-10-01 Normal 180 Day Track
S019 1992-09-23 Normal 180 Day Track
S018 1991-05-01 Normal 180 Day Track
S017
S016 1989-08-23 Normal 180 Day Track
S015 1989-07-24 Normal 180 Day Track
S014
S013 1987-02-09 Normal 180 Day Track
S012 1986-12-04 Normal 180 Day Track
S011 1986-08-05 Normal 180 Day Track
S010 1986-06-24 Normal 180 Day Track
S009 1985-08-12
S008 1984-06-07
S007 1985-06-19
S006 1984-09-04
S005 1984-09-04
S004 1984-06-07
S003 1984-04-26
S002 1984-03-15
S001 1983-10-21

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